BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHO SURGERY TABLE

    MDR report key: 1052134 · Received May 22, 2008

    Report

    Report Number
    MW5007015
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 22, 2008
    Manufacturer
    MIZUHO OSI
    Product Code
    JEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED TO OR FOR REPAIR OF T12 BURST FRACTURE THORACOTOMY APPROACH. PATIENT WAS POSITIONED LATERAL, RIGHT SIDE DOWN, ON JACKSON TABLE. TABLE WAS REQUESTED TO BE LOWERED AND TURNED TO THE OPERATOR'S RIGHT. OPERATOR AT THE HEAD OF THE BED COULD RAISE AND LOWER THE TABLE WITH HAND CONTROL BUT WAS UNABLE TO TILT THE TABLE WITH THE CONTROL. THE ROTATION LOCK BUTTON WAS PUSHED AND THE 180 DEGREE ROTATION KNOB WAS TURNED. THE BED IMMEDIATELY ROTATED WHICH CAUSED THE PATIENT TO FALL TO THE FLOOR UNASSISTED. THE PATIENT WAS FOUND TO HAVE NO SERIOUS DISABILITIES OR LASTING HARM FOLLOWING THE EVENT OR AT PRESENT TIME. THE PATIENT WAS AWAKENED PER ANESTHESIA AND EVALUATED NEUROLOGICALLY. NO NEURO DEFICITS WERE FOUND AND PATIENT WAS TAKEN TO THE PACU. SCHEDULED SURGERY WAS PERFORMED LATER THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SURGERY TABLE JACKSON TABLE JEB MIZUHO OSI 5803

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization